The US Food and Drug Administration (FDA) has granted premarket approval (PMA) for OrganOx’s liver normothermic machine perfusion (NMP) metra system.
Fully automated NMP device, the OrganOx metra system is designed to preserve and transport donor livers in a functioning state for transplantation.
The FDA approval includes the use of the transportable device for liver grafts from donors after circulatory death (DCD) and donors after brain death (DBD).
The device is claimed to be the first fully automated NMP system in the world to receive approval from the FDA for preserving donor livers before transplantation.
It provides warm, oxygenated blood and nutrients to the liver during the crucial time between donation and transplantation.
With rugged and robust design, the metra system offers easy transportation and safe storage of donor livers when not in use.
OrganOx CEO Craig Marshall said: “We are thrilled with this news and excited to be able to bring our technology to the US, which we expect will increase the utilisation of donor organs and thereby reduce waitlist mortality.
“To date, the metra has supported more than 1,200 liver transplants worldwide, with several individual centres in Europe having transplanted more than 100 donor livers using our system.
“There is a clear unmet clinical need for our device in the US where the situation is similar to Europe, with many patients dying on the waitlist and large numbers of donated organs that are not transplanted.”
The company stated that the device has enabled the transplantation teams to assess the donor liver’s function before a transplant.
In August this year, Exact Sciences reported positive data of its Oncoguard Liver liquid biopsy test published in Clinical Gastroenterology and Hepatology.